Convert Swiss francs (CHF) to your currency. This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

The standard ISO 14155:2011 is an assessable standard and hence is certifiable. The standard regards good clinical practices and protocols for the clinical investigations and plans of medical devices. The assessment is carried out following defined protocols in this international standard.

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to.

ISO 14155:redline:2020(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical

Executive Order 14155, titled "Withdrawing the United States from the World Health Organization", is an executive order signed by United States president Donald Trump on January 20, 2025, during the first day of his second presidential term. The order directed the withdrawal of the United States from the World Health Organization.. This executive order marked the …

Sep 15, 2023 · Understanding ISO 14155:2020 is essential. It is a guide to Good Clinical Practice for clinical investigations of medical devices for human subjects. This ultimate guide provides an overview of both the standard and Good Clinical Practices (GCP).

Provides guidance on best practices for operation of EC reviewing clinical investigations of medical devices. Provides possible types of clinical investigations in different clinical development stages and from a regulatory status applies to both pre-and post-market clinical investigations.

ISO 14155 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This second edition cancels and replaces the first edition of ISO 14155-1:2003 and the first edition of ISO 14155-2:2003, which have been technically revised.

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

ISO 14155: 2020 specifies general requirements intended to: assisting sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. This document does not apply to in vitro diagnostic medical devices.